Double Kissing-crush vs Controlled Balloon-crush Techniques For Complex Coronary Bfurcation Lesions

NCT ID: NCT06931574

Last Updated: 2025-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-01

Study Completion Date

2026-12-30

Brief Summary

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The Crush technique for coronary bifurcation lesions has evolved significantly since its introduction to the literature by Colombo et al. in 2003, with several iterations, including double kissing balloon inflation. The main disadvantage of the historical Crush technique is the low success rate of the final kissing balloon inflation. An improvement came with the introduction of double kissing crush stenting aiming for the shorter protrusion and kissing balloon dilation performed before and after main branch stent implantation. The double kissing crush provides a significant reduction in major adverse cardiovascular events compared to Provisional stenting, Crush, and Culotte techniques. Recently, a novel modified mini-crush technique (controlled balloon-crush) has been introduced to the literature and is one of the most up-to-date crush techniques. The main advantage of this technique over the contemporary mini-crush technique is that the side branch can be easily rewired, and the 1:1 size non-compliant balloon can easily pass through the crushed stent structure in the ostial part of the side branch. The basic rationale of this is that the crushing of the side branch stent is done in a more controlled manner (by slowly deflation of the side branch stent balloon), and this causes less disruption of the stent cells. To date, no data compares the mid-term outcomes of double kissing crush and controlled balloon-crush stenting techniques in patients with complex coronary bifurcation lesions. Hence, this study aimed to determine the clinical results of double kissing crush and controlled balloon-crush techniques under mid-term follow-up.

Detailed Description

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Conditions

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Coronary Arterial Disease (CAD) Percutaneous Coronary Intervention (PCI) Bifurcation Coronary Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Controlled balloon-crush Group

No interventions assigned to this group

Double kissing-crush stenting Group

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Aged \>18
* PCI with either DK-crush or Controlled balloon-crush
* Complex coronary bifurcation lesion (Medina 0.1.1, Medina 1.1.1)

Exclusion Criteria

* Non-complex bifurcation anatomy
* Bail-out 2-stent (reverse modified mini-crush)
* ST-elevation myocardial infarction
* Cardiogenic shock status
* In-stent restenosis
* A previous of coronary artery bypass grafting
* Implantation of bare-metal stent
* End-stage hepatic or renal disease
* \<1-year life expectancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sisli Hamidiye Etfal Training and Research Hospital

OTHER

Sponsor Role collaborator

Başakşehir Çam & Sakura City Hospital

OTHER_GOV

Sponsor Role collaborator

Bagcilar Training and Research Hospital

OTHER_GOV

Sponsor Role collaborator

Ankara Etlik City Hospital

OTHER_GOV

Sponsor Role collaborator

Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital

OTHER_GOV

Sponsor Role collaborator

Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital

OTHER

Sponsor Role collaborator

Istanbul Medipol University Hospital

OTHER

Sponsor Role collaborator

Istanbul Mehmet Akif Ersoy Educational and Training Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Ahmet Guner

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Istanbul Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Istanbul Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Fatih Uzun, Professor

Role: CONTACT

902126922000

Abdullah Doğan, MD

Role: CONTACT

Facility Contacts

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Ahmet Güner, MD

Role: primary

05056533335

Abdullah Doğan, MD

Role: backup

Ahmet Güner, MD

Role: primary

+905056533335

Other Identifiers

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2025.03-21

Identifier Type: -

Identifier Source: org_study_id

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